Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)

NCT07164742 · tracked via the Priya Life Science India tracker

Sponsor

Johns Hopkins University

Phase

Not applicable

Started

2026-03-18

Last updated

2026-03-27

Condition(s) studied

TB - TuberculosisTBTB Infection

Investigational drug(s) / intervention(s)

8 week (short arm) Intervention - pulmonary rehabilitation24 week (long arm) Intervention - pulmonary rehabilitation

8 week (short arm) Intervention - pulmonary rehabilitation: 8 weeks (short arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.

24 week (long arm) Intervention - pulmonary rehabilitation: 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.

Study summary

Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age at least 18 years * Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease\* * Not completed more than 2 weeks of TB treatment * Receiving TB care at the outpatient clinics at the TB PuRe study sites * Willingness to complete 48 weeks of study evaluations. * Access to a smartphone. Exclusion Criteria: * Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise) * Multi or extensively drug-resistant TB disease\* * Extrapulmonary TB disease at any clinical sites without pulmonary involvement * TB meningitis or TB of the spine * Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure. * Karnofsky Score \< 40 points * Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy * Bronchodilators and/or corticosteroids inhaled or otherwise.

Primary outcome measure(s)

Six-Minute Walk Test (6MWT) distance (meters) — 48 weeks post enrollment
Mean distance compared between study arms

Trial sites (2)

Facility	City	Region	Status
Yenepoya (Deemed to be University	Mangalore	India	Recruiting
Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center	Pune	India	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07164742 on ClinicalTrials.gov ↗ ← All trials in India